Superpipe Angiographic Catheter— 510(k) K193647

Substantially Equivalent

Suzhou Hengrui Disheng Medical Co., Ltd.

FDA 510(k) clearance K193647 for Superpipe Angiographic Catheter, Substantially Equivalent on 2020-07-29. Applicant: Suzhou Hengrui Disheng Medical Co., Ltd..

Clearance details

Applicant: Suzhou Hengrui Disheng Medical Co., Ltd.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2019-12-30
Decision date: 2020-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.